Sr. Manager, QC Microbiology

Legend Biotech USA, Inc.; Raritan (NJ); On-site; USD 146,000 - 192,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401(k) with company match

Parental leave

Paid time off

Flexible spending accounts

Life and AD&D insurance

Job summary

Legend Biotech USA, Inc. is seeking a Sr. Manager, QC Microbiology in Raritan, NJ, to lead the QC microbiology laboratories supporting CAR-T cell therapy manufacturing.

The role includes staff leadership, data review, method validation, investigations, and cross-functional collaboration to ensure compliance with cGMP and regulatory requirements. The ideal candidate holds a B.S. in Science with 12–14 years of related experience, including aseptic manufacturing and at least 3–5 years in a

Qualifications

• Bachelor's Degree in Science or equivalent required.
• 12–14 years of relevant experience preferred, with aseptic manufacturing exposure.
• 3–5 years of leadership experience required.
• Experience with Quality systems and cGMP FDA/EU guidance.
• Strong communication and cross-functional collaboration skills.

Responsibilities

• Train and develop staff with cGMP and safety in mind.
• Manage QC microbiology materials, testing, and investigations.
• Oversee instrument maintenance, calibration, and qualification.
• Lead method verification, qualification, validation or transfer activities.
• Collaborate with QA, Manufacturing, Engineering and Maintenance.

Skills

Leadership

QC Microbiology

cGMP knowledge

Regulatory knowledge

Data analysis

Education

Bachelor's Degree in Science

Job description

Legend Biotech is a global biotechnology company dedicated to treating and, one day, curing life-threatening diseases. Headquartered in Bridgewater, New Jersey, we are advancing the next generation of cell therapy through a portfolio of innovative technologies, including autologous, allogeneic, and in vivo cell therapy approaches. Our research spans chimeric antigen receptor T-cell (CAR-T), T-cell receptor (TCR-T), natural killer (NK) cell-based therapies, and other emerging platforms designed to transform the treatment of serious diseases. From our global network of research and development sites, we are committed to discovering and developing safe, effective, and cutting-edge therapies for patients worldwide.

Legend Biotech entered into a global collaboration agreement with Johnson & Johnson to jointly develop and commercialize CARVYKTI® (ciltacabtagene autoleucel; cilta-cel). Through this strategic partnership, we combine complementary expertise and capabilities to advance innovative immunotherapies for patients living with multiple myeloma.

Legend Biotech is seeking a Sr. Manager, QC Microbiology as part of the Quality team based in Raritan, NJ.

Role Overview

The Sr. Manager, QC Microbiology, is an exempt level position with responsibilities for managing the operation and workflow of the quality control microbiology laboratories in support of cell therapy manufacturing. This includes hiring, development and performance management of staff, reviewing/approving laboratory test data, developing and implementing microbiology procedures and methods, supporting laboratory investigations and ownership of various QC microbiology department projects. The role develops and implements long-term strategies and manages a team of people leaders and technical professionals within the QC department based on assigned work, direction, coaching and developing capabilities.

Key Responsibilities

• Ensuring adequate training (skills-based, cGMP and safety) of people leaders and associates within the department.
• Manage Raw material, in-process, environmental monitoring/utility, product release, and stability testing.
• Manage and support Investigation of laboratory non-conformances (events, deviations, and invalid assays).
• Maintenance, calibration and qualification of laboratory instruments and equipment.
• Test method verification, qualification, validation and/or transfer activities in the QC Micro laboratories.
• Process Performance Qualification and Continued Process Verification activities associated with QC microbiology laboratory testing.
• Providing expertise in troubleshooting complex laboratory issues and demonstrating strong reasoning skills in support of ongoing laboratory investigations.
• Maintain detailed knowledge of industry guidelines/trends, regulatory requirements, and applicable pharmacopeia while remaining current in on-the-job training requirements.
• Collaborate with Quality Assurance, Manufacturing, Technical Operations, Engineering and Maintenance to support business needs.
• Contribute to global strategies related to QC laboratories which align with compliance and business objectives as well as the overall corporate vision.
• Manage departmental budget and resources; prepare staffing plans. Make adjustments to roles and responsibilities of department to meet business needs.
• Perform tasks in a manner consistent with the safety policies, quality systems and cGMP requirements.
• Monitor QC method performance through trending analysis for on QC generated test results.
• Represent department during internal and external audits.
• Job duties performed routinely require exposure to and handling of biological materials and hazardous chemicals.
• Works in a collaborative team setting with quality counterparts that include Quality Assurance, Manufacturing Operations, Technical Operations, Engineering and Maintenance, Supply Chain and Planning.
• Other duties will be assigned, as necessary.

Requirements

• A minimum of a Bachelor's Degree in Science, Biology or equivalent technical discipline is required.
• A Minimum of 12 to 14 years relevant work experience is required. It is preferable that the candidate has experience working in an aseptic manufacturing facility, preferably in microbiology quality control laboratory, quality assurance, or cell therapy. A minimum of 3-5 years of leadership experience is also required.
• Experience working with Quality systems is required.
• Extensive knowledge of chemical, biochemical and microbiological concepts is required.
• Ability to apply basic and advanced mathematical concepts (including statistics) in the evaluation of laboratory data is required.
• Knowledge of cGMP regulations and FDA/EU guidance is required.
• Comfortable with speaking and interacting with inspectors.
• Good written and verbal communication skills are required.
• This position may require up to 10% domestic or international travel as business demands.
• Detailed knowledge and understanding of current Good Manufacturing Practices (cGMP) and current Good Tissue Practices (cGTP) related to CAR-T manufacturing or cell processing.
• Proven people management and leadership experience are required.
• In-depth knowledge and experience in biopharmaceutical analysis method verification is preferred.
• Experience in microbiological test methods and EM is preferred.
• Ability to quickly process complex information and often make critical decisions with limited information.
• Ability to handle multiple priorities on a daily basis while being flexible and responsive to frequently shifting priorities.
• Proficient in applying excellence tools and methodologies.
• Ability to summarize and present results, and experience with team-based collaborations is a requirement.
• Experience in developing and setting long-term objectives for individual and teams.
• Have a high sense of responsibility and professionalism with excellent organizational skills, analytical judgment and communication skills.
• Able to work cross functionally and under pressure.

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Benefits and Paid Time Off

Medical, dental, and vision insurance as well as a 401(k) retirement plan with a company match that vests fully on day one. We offer eight (8) weeks of paid parental leave after just three (3) months of employment, and a paid time off policy that includes vacation time, personal time, sick time, floating holidays, and eleven (11) company holidays. Additional voluntary benefits include flexible spending and health savings accounts, life and AD&D insurance, short- and long-term disability coverage, legal assistance, and supplemental plans such as pet, critical illness, accident, and hospital indemnity insurance. We also provide voluntary commuter benefits, family planning and care resources, well-being initiatives, and peer-to-peer recognition programs; demonstrating our ongoing commitment to building a culture where our people feel empowered, supported, and inspired to do their best work.

Other Types of Pay

Performance-based bonus and/or equity is available to employees in eligible roles.

Pay Range (Base Pay)

$146,410—$192,164 USD

Please note: These benefits are offered exclusively to permanent full-time employees. Contractors are not eligible for benefits through Legend Biotech.

Work Authorization & Employment Eligibility

Applicants must be authorized to work in the United States. As part of our commitment to maintaining a lawful workforce and ensuring compliance with federal employment regulations, we participate in the E-Verify program. If you are selected for employment, you will be required to complete the Form I-9 process, and your employment eligibility will be verified through E-Verify in accordance with applicable federal law. We are committed to providing a fair, transparent, and welcoming hiring experience for all candidates.

EEO Statement

It is the policy of Legend Biotech to provide equal employment opportunities without regard to actual or perceived race, color, creed, religion, national origin, ancestry, citizenship status, age, sex or gender (including pregnancy, childbirth, related medical conditions and lactation), gender identity or gender expression (including transgender status), sexual orientation, marital status, military service and veteran status, disability, genetic information, or any other protected characteristic under applicable federal, state or local laws or ordinances.

Employment is at-will and may be terminated at any time with or without cause or notice by the employee or the company.

For information related to our privacy notice, please review: Legend Biotech Privacy Notice.